Gemcitabine and Imatinib Mesylate in Treating Patients With Recurrent or Metastatic Non-Small Cell Lung Cancer

NCT00323362 | Terminated Phase 2 Results

• 5 other identifiers: CDR0000539557P30CA0727200305030220060014NJ1505
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 3

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine together with imatinib mesylate may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine together with imatinib mesylate works in treating patients with recurrent or metastatic non-small cell lung cancer.

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancer; stage IV non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients Who Meet Critieria for Response

  Response is considered Partial Response or Complete Response as per RECIST criteria. Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.

  2 years

Secondary Outcomes (2)

• Time to Progression

  2 years

• 1-year Survival

  3 years

Study Arms (1)

Gemcitabine hydrochloride and imatinib mesylate

EXPERIMENTAL

Drug: gemcitabine hydrochloride; Drug: imatinib mesylate

Interventions

gemcitabine hydrochloride DRUG

1000 mg/m2 given intravenously at a FDR of 10 mg/m2/min on Days 3 and 10, every 21 days.

Gemcitabine hydrochloride and imatinib mesylate

imatinib mesylate DRUG

400 mg/day orally, given Days 1-5 and 8-12 every 21 days

Gemcitabine hydrochloride and imatinib mesylate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed non-small cell cancer * Recurrent disease after adjuvant treatment OR progressive disease after 1 prior treatment for recurrent or metastatic disease * Received at least 1 prior chemotherapy regimen and meets the following criteria: * No more than 1 prior chemotherapeutic regimen in the recurrent or metastatic setting * Patients who received prior chemotherapy in the adjuvant setting are eligible when 1 of the following criteria is met: * In first recurrence (after 1 prior regimen) * Received first-line chemotherapy in the recurrent setting after 2 prior regimens * Measurable disease * Must have ≥ 1 measurable target lesion outside prior radiotherapy field OR radiologic confirmation of disease progression within a prior radiotherapy field * No known or untreated brain metastases or carcinomatous meningitis * Clinically stable, treated brain metastases allowed provided it has been \> 7 days since prior steroids PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Life expectancy ≥ 3 months * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * AST and ALT ≤ 2.5 times ULN * Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after completion of study treatment * Able to swallow oral medication * No concurrent medical condition that would preclude study compliance * No history of allergic reaction to compounds of similar chemical or biological composition to gemcitabine hydrochloride or imatinib mesylate * No uncontrolled illness that would preclude study compliance, including any of the following: * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia requiring therapy * Myocardial infarction within the past 6 months * Active infection * No New York Heart Association class III-IV congestive heart failure * No chronic liver disease (i.e., chronic active hepatitis, cirrhosis) * No HIV positivity * No other primary malignancies within the past 5 years, except carcinoma in situ of the cervix or nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) * At least 3 weeks since prior anti-vascular endothelial growth factor therapy and recovered * At least 3 weeks since prior radiotherapy and recovered * More than 28 days since prior and no other concurrent investigational or commercial agents * More than 2 weeks since prior major surgery * No prior gemcitabine hydrochloride or imatinib mesylate for metastatic disease * No prior tyrosine kinase inhibitor, except for gefitinib or erlotinib hydrochloride * No concurrent therapeutic warfarin (prophylactic warfarin therapy ≤ 1 mg daily allowed) * No other concurrent medications that would preclude study compliance * No concurrent chronic systemic corticosteroids

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Cancer Institute (NCI): collaborator
• Novartis: collaborator

Study Sites (3)

Cancer Institute of New Jersey at Hamilton

Hamilton, New Jersey, 08690, United States

Location

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08903, United States

Location

Saint Peter's University Hospital

New Brunswick, New Jersey, 08903, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Gemcitabine; Imatinib Mesylate

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines

Results Point of Contact

• Title: Dr. Joseph Aisner, MD
• Organization: Rutgers Cancer Institute of New Jersey

aisnerjo@cinj.rutgers.edu; rizzoji@cinj.rutgers.edu; zelinsta@cinj.rutgers.edu

732-235-8675

Study Officials

• Mika Sovak, MD, PhD

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2006
• First Posted: May 9, 2006
• Study Start: April 1, 2006
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: May 22, 2014
• Results First Posted: May 22, 2014

Record last verified: 2014-04

Locations

US (3)